Analysis of intercurrent human immunodeficiency virus type 1 infections in phase I and II trials of candidate AIDS vaccines. AIDS Vaccine Evaluation Group, and the Correlates of HIV Immune Protection Group.
Among 2099 uninfected subjects in phase I and II trials of candidate AIDS vaccines, 23 were diagnosed with intercurrent human immunodeficiency virus type 1 (HIV-1) infection. High-risk sexual exposures accounted for 17 infections, and intravenous drug use accounted for 6. Four subjects received placebo, 13 received a complete immunization schedule (> or = 3 injections), and 6 were partially immunized (< or = 2 injections). There was no significant difference between vaccine recipients and control groups in incidence of HIV-1 infection, virus load, CD4 lymphocyte count, or V3 loop amino acid sequence. In summary, 19 vaccinated subjects acquired HIV-1 infection during phase I and II trials, indicating that immunization with the products described is < 100% effective in preventing or rapidly clearing infection. Laboratory analysis suggested that vaccine-induced immune responses did not significantly affect the genotypic or phenotypic characteristics of transmitted virus or the early clinical course of HIV-1 infection.
Graham
B S
BS
Vanderbilt University School of Medicine, Nashville, Tennessee 37232-2582, USA. barney.graham@mcmail.vanderbilt.edu
McElrath
M J
MJ
Connor
R I
RI
Schwartz
D H
DH
Gorse
G J
GJ
Keefer
M C
MC
Mulligan
M J
MJ
Matthews
T J
TJ
Wolinsky
S M
SM
Montefiori
D C
DC
Vermund
S H
SH
Lambert
J S
JS
Corey
L
L
Belshe
R B
RB
Dolin
R
R
Wright
P F
PF
Korber
B T
BT
Wolff
M C
MC
Fast
P E
PE
D016915:AIDS Vaccines / Q000627:therapeutic use*; D000328:Adult; D000595:Amino Acid Sequence; D018791:CD4 Lymphocyte Count; D005260:Female; D015483:HIV Antibodies / Q000032:analysis; D015699:HIV Envelope Protein gp120 / Q000032:analysis / Q000235:genetics; D015658:HIV Infections / Q000175:diagnosis* / Q000517:prevention & control* / Q000628:therapy; D015497:HIV-1; D006801:Humans; D007110:Immunity, Active; D015994:Incidence; D008297:Male; D008875:Middle Aged; D008969:Molecular Sequence Data; D009500:Neutralization Tests; D010446:Peptide Fragments / Q000032:analysis / Q000235:genetics; D012309:Risk-Taking; D017421:Sequence Analysis; D015819:Substance Abuse, Intravenous; D019562:Viral Load
D016915:AIDS Vaccines; D015483:HIV Antibodies; D015699:HIV Envelope Protein gp120; C059762:HIV envelope protein gp120 (305-321); D010446:Peptide Fragments